MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIBIAL BASE IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71440192

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 07/21/2020

Event Type  Injury  

Event Description

It was reported that in procedure tka, the device was broke during tibial implantation.The procedure had a delay between 0-30 min.It is unknown how was the procedure finished.Any other issue that could affect the patient's condition was not reported by this event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

New information was received.Therefore, it was an updated of b5: description / d4: lot number and exp date / h4: manufacturing date.

Event Description

It was reported that during the procedure tka, the device was broke inside the patient during tibial implantation.All pieces were recovered.The procedure had a delay between 0-30 min and the surgery was finish with a backup from a competitor.The patient condition is unknown.

Manufacturer Narrative

The device, used in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.The device was manufactured in 2009.According to clinical/medical investigation, this case reports that during a tka procedure, the impactor broke inside the patient.Per email communication, all of the broken pieces were removed from the patient, and the procedure was completed using a competitor device without any significant delay or patient injury.Therefore, since no patient harm is alleged, no further assessment is warranted at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.The device failure in this complaint have been identified and confirmed.No investigation is necessary as this failure mode has been previously identified.Corrective actions have been previously implemented by the supplier in september of 2013 to prevent recurrence of this failure mode.The device in this complaint were manufactured prior to the implementation of those corrective actions.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.No further actions are being taken at this time.

• Brand Name: GII TIBIAL BASE IMPACTOR
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10427950
• MDR Text Key: 203622656
• Report Number: 1020279-2020-04057
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010214386
• UDI-Public: 03596010214386
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71440192
• Device Catalogue Number: 71440192
• Device Lot Number: 09MM04030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention